As you might recall, the Tribune's reporting dealt in part with products marketed by Wellshire Farms and sold at Whole Foods as "gluten-free" even though, on investigation, they appear to have harmful amounts of gluten in them.
* In a follow-up article, "A recipe for disaster: Whole Foods' handling of chocolate bar shows how warnings fail" (November 23, 2008), reporter Sam Roe critiques the unreliability of some manufacturing processes as well as the warnings and assurances found on products sold at Whole Foods. Curiously, the article's gluten-free example has to do with tortillas that seem to qualify as gluten-free even though they are apparently made at high risk of cross-contamination.
* For at least a limited time, you can hear an informative interview with Roe on Chicago's Steve and Johnnie Show. (Co-host Steve King has celiac sprue.)Enjoy Life Foods president Scott Mandell issued a statement saying that "This kind of investigation is long overdue."
* Wellshire Farms president Louis Colameco has posted a response to the article. As you can see, the response focuses largely on one product and avoids addressing many of the serious issues—such as the >200ppm levels of gluten found in several of Wellshire's "gluten-free" products—raised in Sam Roe's article and this blog.
QUALITY CONTROL* I have yet to see any response or statement from Whole Foods.
November 21, 2008
To Whom It May Concern:
There have been some questions about the status and production of our Wellshire and Garrett County gluten free Dino Bites as a result of a recent article printed in the Chicago Tribune. Our understanding after speaking with the author is that this article relates solely to reactions from children with anaphylaxis, that is, with severe reactions to any level of allergens.
We have not discontinued making this product, but we are in the process of improving its formulation. Our products are governed by the USDA and its regulations, not the FDA's regulations. We are in complete compliance with the USDA regulations. However, in light of a new FDA proposal under consideration to re-define "gluten-free" to a lower level of gluten parts per million (ppm) in the product than is currently allowed under FDA regulated foods, we are also working on our products conforming to their definition of "gluten-free." As the FDA considers setting a new regulation, this does not affect our legal obligation to comply with USDA regulations, which specifically govern the food products we produce. Our effort to reduce permitted gluten content is a proactive improvement of our product to meet our customer's needs, and an effort to comply with the strictest standards.
Our Wellshire products are tested at a level of 200 ppm or less, which is equivalent to 99.98% gluten free. The FDA is now considering a new proposal that would reduce the amount of gluten to be 20 ppm or to 99.998% gluten free. This will be difficult to achieve as wheat and other grains can become cross contaminated from growth in the fields, or milling in the combines. It becomes very, very difficult if not impossible to control.
The FDA interprets the definition of gluten free to concern the level or amount of gluten in the product; thereby recognizing that there is still a contaminate of gluten in the product. The USDA bases the gluten free claim on the identity of the ingredients listed in the product, that is prohibiting the use of ingredients that contain gluten, such as wheat, barley, or rye.
It may take a month more to fully complete the transition of the Wellshire products, but the Dino Bites will be returning to store shelves as soon as possible. This new Dino Bite will be a better tasting product, suitable for child and adult palates alike.
Wellshire is committed to improving the quality of our products. We apologize for any inconvenience this confusion between the USDA and FDA regulations may have caused our customers.
Louis B. Colameco, III President